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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014572
Receipt No. R000016939
Scientific Title Hypoxia imaging with 18F-Misonidazole PET in brain metastasis
Date of disclosure of the study information 2014/07/22
Last modified on 2018/01/17

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Basic information
Public title Hypoxia imaging with 18F-Misonidazole PET in brain metastasis
Acronym Hypoxia imaging with FMISO PET in brain metastasis
Scientific Title Hypoxia imaging with 18F-Misonidazole PET in brain metastasis
Scientific Title:Acronym Hypoxia imaging with FMISO PET in brain metastasis
Region
Japan

Condition
Condition metastatic brain tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify whether it is possible to evaluate hypoxia evaluation for matastatic brain tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SUV(Standardized Uptake Value),lesion to cerebellum ratio,Tumor/blood ratio
Key secondary outcomes local control survival rate, overall survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 FMISO PET imaging
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)metastatic brain tumor whose maximum diameter is equal to or above 5mm in MRI.
2)no treatment history with radiotherapy or surgery to metastatic brain tumor.
3)no meningitis carcinomatosa and dissemination in MRI.
4)KPS equal to or above 70%.
5)Pathologically (histologically or cytologically) proven diagnosis from extra cranial lesion.
6)Patients must sign a study-specific informed consent prior to study entry.
Key exclusion criteria 1)patient who can rest in dorsal position for about one hour
2)patient with severe claustrophobia
3)nonage
4)expectant and nursing mothers
5)patient judged unsuitable as a trial subject by the principal investigator
Target sample size 70

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroki Shirato
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Zip code
Address Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo,Hokkaido
TEL 011-706-5977
Email huvrad-secretary@rad.med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Mori
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Zip code
Address Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo,Hokkaido
TEL 011-706-5977
Homepage URL
Email tamori-tym@umin.ac.jp

Sponsor
Institute Departments of Radiotherapy, Hokkaido University Hospital
Institute
Department

Funding Source
Organization Department of Radiation Medicine Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 16 Day
Last modified on
2018 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016939

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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